Morbid or severe obesity is a chronic pathology of multifactorial etiology that affects 4.3% of the French population. In these patients, eating disorders are frequent and must be managed as they are considered risk factors with poorer weight prognosis and lower quality of life. Some authors have proposed that the concept of food addiction (i.e., the existence of an addiction to certain foods rich in sugar, fat and/or salt) may make it possible to identify, among obese patients, a subgroup of patients that is more homogeneous in terms of diagnosis and prognosis. Food addiction is common in obese patients and is associated with higher levels of depression, anxiety, impulsivity, emotional eating and poorer quality of life. Nevertheless, we do not know the impact of managing this addiction on the future of these patients (food addiction, weight, comorbidities, quality of life). Telephone-based cognitive behavioral therapy intervention (Tele-CBT) is a treatment of choice for addictions, but there are inequalities in access to this treatment (distance between home and hospital, limited local resources of caregivers, constraints in patient availability) which require the therapeutic framework to be adapted to these constraints. A short Tele-CBT program has demonstrated its effectiveness in reducing bulimic hyperphagia in these patients (Cassin et al. 2016), but its effectiveness on food addiction, Body Mass Index and the evolution of metabolic complications related to obesity is still unknown. The evaluation of this program was limited to 6 weeks (American study), and we do not know if these results can also be extrapolated to France. The main hypothesis of this study is that in patients suffering from severe or morbid obesity and with food addiction, the performance of tele-CBT (intervention group: 12 sessions for 18 weeks) will be accompanied by a significant medium-term decrease in the prevalence of food addiction compared to usual management (control group).
Morbid or severe obesity is a chronic pathology of multifactorial etiology that affects 4.3% of the French population. In these patients, eating disorders are frequent and must be managed as they are considered risk factors with poorer weight prognosis and lower quality of life. Some authors have proposed that the concept of food addiction (i.e., the existence of an addiction to certain foods rich in sugar, fat and/or salt) may make it possible to identify, among obese patients, a subgroup of patients that is more homogeneous in terms of diagnosis and prognosis. Food addiction is common in obese patients and is associated with higher levels of depression, anxiety, impulsivity, emotional eating and poorer quality of life. Nevertheless, we do not know the impact of managing this addiction on the future of these patients (food addiction, weight, comorbidities, quality of life). Telephone-based cognitive behavioral therapy intervention (Tele-CBT) is a treatment of choice for addictions, but there are inequalities in access to this treatment (distance between home and hospital, limited local resources of caregivers, constraints in patient availability) which require the therapeutic framework to be adapted to these constraints. A short Tele-CBT program has demonstrated its effectiveness in reducing bulimic hyperphagia in these patients (Cassin et al. 2016), but its effectiveness on food addiction, Body Mass Index and the evolution of metabolic complications related to obesity is still unknown. The evaluation of this program was limited to 6 weeks (American study), and we do not know if these results can also be extrapolated to France. The main hypothesis of this study is that in patients suffering from severe or morbid obesity and with food addiction, the performance of tele-CBT (intervention group: 12 sessions for 18 weeks) will be accompanied by a significant medium-term decrease in the prevalence of food addiction compared to usual management (control group).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
154
12 sessions of CBT using a standardized approach
Department of endocrinology-diabetology-nutrition, University Hospital, Angers
Angers, France
Nutrition Department, University Hospital, Brest
Brest, France
Transversal Clinical Nutrition Unit, University Hospital, Caen
Caen, France
Transversal Nutrition Unit, Hospital, Cherbourg
Cherbourg, France
Nutrition Department, University Hospital, Nantes
Nantes, France
Department of Internal Medicine, Endocrinology and Metabolic Diseases, University Hospital, Poitiers
Poitiers, France
Endocrinology, diabetology and nutrition department, University Hospital, Reims
Reims, France
Endocrinology, diabetology and nutrition department, University Hospital, Rennes
Rennes, France
Metabolic and nutritional exploration, University Hospital, Tours
Tours, France
Percentage of patients without food addiction
Yale Food Addiction Scale 2.0 (food addiction is defined by the existence of at least 2 out of 11 criteria for food addiction and associated emotional distress)
Time frame: 18 weeks after randomization
Evolution of Percentage of patients without food addiction during follow-up
Yale Food Addiction Scale 2.0 (food addiction is defined by the existence of at least 2 out of 11 criteria for food addiction and associated emotional distress)
Time frame: From baseline, up to 9 months
Evolution of number of criteria for food addiction
Yale Food Addiction Scale 2.0 (food addiction is defined by the existence of at least 2 out of 11 criteria for food addiction and associated emotional distress)
Time frame: From baseline, up to 9 months
Weight/BMI evolution
Weight and height measurement
Time frame: From baseline, up to 9 months
Evolution of the waist-to-hip ratio
Waist and hip measurement
Time frame: From baseline, up to 9 months
Evolution of Body Composition
Impedancemetry
Time frame: From baseline, up to 9 months
Existence and evolution psychiatric and addictive disorders
Mini International Neuropsychiatric Interview 5.0.0 (MINI 5.0.0)
Time frame: From baseline, up to 18 weeks
Existence and evolution of depression
Beck Depression Inventory (BDI)
Time frame: From baseline, up to 9 months
Existence and evolution of bulimic hyperphagia
Binge Eating Scale (BES)
Time frame: From baseline, up to 9 months
Existence and evolution of an alcohol use disorder
Alcohol Use Disorder Inventory Test (AUDIT)
Time frame: From baseline, up to 9 months
Existence and evolution of a Smoking Disorder
Fagerström Test for Nicotine Dependence (FTND)
Time frame: From baseline, up to 9 months
Existence and evolution of food cravings
Food Cravings Questionnaire-Trait-reduced (FCQ-T-r)
Time frame: From baseline, up to 9 months
Existence and evolution of emotional eating
Dutch Eating Behavior Questionnaire (DEBQ)
Time frame: From baseline, up to 9 months
Evolution of quality of life
Quality of Life, Obesity and Dietetics (QOLOD)
Time frame: From baseline, up to 9 months
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